Device Classification Name |
System, Test, Radioallergosorbent (Rast) Immunological
|
510(k) Number |
K200825 |
Device Name |
NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum pratense |
Applicant |
Hycor Biomedical |
7272 Chapman Avenue |
Garden Grove,
CA
92841
|
|
Applicant Contact |
Irene M. Guzman |
Correspondent |
Hycor Biomedical |
7272 Chapman Avenue |
Garden Grove,
CA
92841
|
|
Correspondent Contact |
Irene M. Guzman |
Regulation Number | 866.5750
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/30/2020 |
Decision Date | 06/26/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|